Blood Pressure Reduction, Stroke Prevention
Conditions
Brief summary
The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic designed for stroke patients and was established to provide a comprehensive approach to stroke risk factor reduction. The goal of this study will be more effective than usual care at reducing blood pressure in patients with poorly controlled blood pressure after an ischemic or hemorrhagic stroke or transient ischemic attack.
Detailed description
STEP clinic patients will receive personalized goals, instructions to self-monitor, a blood pressure monitor, prescription medications, sleep apnea screening, dietary counseling, and more frequent follow-up if needed. A stroke neurologist will see patients in the usual care group and recommendations will be sent to their primary care providers.
Interventions
BEHAVIORALSTEP Clinic
Patients will visit with STEP clinic staff (including a stroke nurse practitioner or stroke doctor) to receive personalized goals, stroke education (including diet and exercise), instructions to self-monitor using blood pressure cuff, and prescription medications Patient will be scheduled for additional clinic follow-up or be contacted for telephone follow-up for management of your blood pressure. Questionnaires will be administered to determine medication adherence and persistence (following instructions for prescribed medication), disability, depression, cognition, self-efficacy, and sleep apnea. The care plan determined by the STEP clinic will be shared with the patient's primary care provider.
BEHAVIORALUsual Care
Patients will complete questionnaires related to medical history and health behaviors prior to initial visit. After being seen by the stroke neurologist, patients may be scheduled to return to the stroke clinic according the doctor's recommendations. Recommendations for blood pressure and risk factor monitoring will be sent to primary care providers.
Sponsors
Georgetown University
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Clinical ischemic stroke, intracerebral hemorrhage, or transient ischemic attack * Plan to discharge home or to short stay inpatient rehab after stroke * Two of following required: * History of hypertension (prior to hospitalization) * Hospital blood pressure ≥ 140/90 on two or more occasions during hospitalization * Discharge home on blood pressure medication * Willingness and ability to follow-up in University of Texas Physicians stroke clinic
Exclusion criteria
* Modified Rankin scale (mRs) \> 3 at enrollment * Terminal illness * Chronic kidney disease stage 4 or greater (eGFR \< 30) * Pregnancy * Symptomatic flow limiting carotid stenosis without plan for intervention prior to clinic visit * Stroke etiology presumed unrelated to atherosclerotic risk factors (amyloid angiopathy, vasculitis, malignancy associated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daytime ambulatory systolic blood pressure | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nighttime ambulatory systolic blood pressure | 6 months | — |
| Nighttime ambulatory diastolic c blood pressure | 6 months | — |
| Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure | 6 months | — |
| Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure | 6 months | — |
| Number of participants who are adherent to blood pressure medications | 6 months | — |
| Daytime ambulatory diastolic blood pressure | 6 months | — |
| Number of patient monitoring blood pressure at home | 6 months | — |
| Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form | 6 months | — |
| Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey | 6 months | — |
| Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale | 6 months | — |
| Number of composite cardiovascular events | 6 months | cardiac death, myocardial infarction, ischemic stroke, hemorrhagic stroke |
| Depressive Symptoms as assessed by Patient Health Questionnaire 9 | 6 months | — |
Countries
United States
Outcome results
None listed